H-pylori Infection With Disease Activity in Systemic Lupus Erythematosus and Rheumatoid Arthritis

Not yet recruiting

• Conditions: Helicobacter Pylori Infection
• Interventions: Other: Full history , clinical examination, assesment of disease activity ,Laboratory investigations ( CBC , ESR, CRP Serum creatinine and blood urea, Random plas

• Registration Number: NCT06586567
• Lead Sponsor: Assiut University

Brief Summary

To find the relation of Helicobacter pylori with disease activity in SLE and RA

Detailed Description

H. pylori is a widespread, spiral-shaped, flagellated Gram-negative bacterium usually infects the gastric mucosa.Its seropositivity increases with age as it affects about eighty percent of the middle-aged adults in the developing countries and about twenty-five to fifty percent in the western populations.The relation between infection and autoimmune diseases has been previously investigated. Many Gram-negative bacteria as salmonella, shigella, and chlamydia were confirmed to be associated with the development of reactive arthritis.These bacteria have been found to stimulate the host immune response due to the presence of lipopolysaccharides and other antigenic molecules that can cause inflammation.It has been previously hypothesized that H. pylori can induce such immune host response through many mechanisms as the molecular mimicry and antigenic similarity, disruption of the tolerogenic immune response, and activation of the polyclonal lymphocytes leading ultimately to the imbalance between T regulatory/Th17 cells in addition to the induction of autoantibody production

Study Timeline

• Study First Submitted: 2024-02-06
• Status Verified: 2024-09
• Study Start: 2024-09-04
• Study First Submitted QC: 2024-09-04
• Last Update Submitted: 2024-09-04
• Study First Posted: 2024-09-06
• Last Update Posted: 2024-09-06
• Primary Completion: 2025-02
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. patients with SLE and RA who were admitted to Rheumatology unit in Internal medicine department, Assuit University Hospital will be enrolled in this study

Exclusion Criteria

• Any patient or control known to have treatment for H. pylori or taking antibiotic treatment for the previous three months 2- Patients receiving biologic therapy 3-Patients known to have diabetes mellitus, autoimmune thyroid disease or autoimmune hepatitis or any other autoimmune

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1 (SLE group):	Full history , clinical examination, assesment of disease activity ,Laboratory investigations ( CBC , ESR, CRP Serum creatinine and blood urea, Random plas	50 patients fulfilling the1997 revised American Collage of Rheumatology classification criteria for SLE according to (Hochberg, 1997)., and h_pylori positive
Group 2 (RA group):	Full history , clinical examination, assesment of disease activity ,Laboratory investigations ( CBC , ESR, CRP Serum creatinine and blood urea, Random plas	50 RA patients diagnosed according to the American college of rheumatology (ACR)-EULAR RA classification criteria 2010. And H_pylori positive
Group 3	Full history , clinical examination, assesment of disease activity ,Laboratory investigations ( CBC , ESR, CRP Serum creatinine and blood urea, Random plas	50 heqlthy age and sex matched adults were selected as control group

Primary Outcome Measures

Name	Time	Method
Prevalence of activity of SLE and RA after treatment of H Pylori infection	2 years	Prevalence of activity of SLE and RA after treatment of H Pylori infection